EN ISO 8536-4:2004

SLOVENSKI STANDARD
01-marec-2005
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Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2004)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2004)
Matériel de perfusion a usage médical - Partie 4: Appareils de perfusion non
réutilisables, a alimentation par gravité (ISO 8536-4:2004)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2004
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 8536-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2004
ICS 11.040.20
English version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2004)
Matériel de perfusion à usage médical - Partie 4: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Infusionsgeräte für Schwerkraftinfusionen zur einmaligen
(ISO 8536-4:2004) Verwendung (ISO 8536-4:2004)
This European Standard was approved by CEN on 29 July 2004.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2004: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 8536-4:2004) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection equipment for medical and pharmaceutical use" in
collaboration with Technical Committee CEN/TC 205 “Non-active medical devices”, the
secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by February 2005, and conflicting national
standards shall be withdrawn at the latest by February 2005.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 8536-4:2004 has been approved by CEN as EN ISO 8536-4:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 8536-4
Third edition
2004-08-15
Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
Matériel de perfusion à usage médical —
Partie 4: Appareils de perfusion non réutilisables, à alimentation par
gravité
Reference number
ISO 8536-4:2004(E)
©
ISO 2004
ISO 8536-4:2004(E)
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ii © ISO 2004 – All rights reserved

ISO 8536-4:2004(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 General requirements. 1
4 Designation. 4
4.1 Infusion set. 4
4.2 Air-inlet device. 4
5 Materials. 4
6 Physical requirements. 5
6.1 Particulate contamination. 5
6.2 Leakage. 5
6.3 Tensile strength. 5
6.4 Closure-piercing device. 5
6.5 Air-inlet device. 5
6.6 Tubing. 6
6.7 Fluid filter. 6
6.8 Drip chamber and drip tube . 6
6.9 Flow regulator. 6
6.10 Flow rate of infusion fluid . 6
6.11 Injection site. 6
6.12 Male conical fitting. 6
6.13 Protective caps. 6
7 Chemical requirements. 7
7.1 Reducing (oxidizable) matter. 7
7.2 Metal ions. 7
7.3 Titration acidity or alkalinity . 7
7.4 Residue on evaporation. 7
7.5 UV absorption of extract solution . 7
8 Biological requirements. 7
8.1 General. 7
8.2 Sterility. 7
8.3 Pyrogenicity. 7
8.4 Haemolysis. 7
8.5 Toxicity. 8
9 Labelling. 8
9.1 Unit container. 8
9.2 Shelf or multi-unit container . 8
10 Packaging. 9
Annex A (normative) Physical tests . 10
Annex B (normative) Chemical tests. 14
Annex C (normative) Biological tests. 16
Bibliography . 17

ISO 8536-4:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8536-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 8536-4:1998) which has been technically
revised.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
 Part 1: Infusion glass bottles
 Part 2: Closures for infusion bottles
 Part 3: Aluminium caps for infusion bottles
 Part 4: Infusion sets for single use, gravity feed
 Part 5: Burette infusion sets for single use, gravity feed
 Part 6: Freeze drying closures for infusion bottles
 Part 7: Caps made of aluminium-plastics combinations for infusion bottles
 Part 8: Infusion equipment for use with pressure infusion apparatus
 Part 9: Fluid lines for use with pressure infusion equipment
 Part 10: Accessories for fluid lines for use with pressure infusion equipment
 Part 11: Infusion filters for use with pressure infusion equipment

iv © ISO 2004 – All rights reserved

INTERNATIONAL STANDARD ISO 8536-4:2004(E)

Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
1 Scope
This part of ISO 8536 specifies requirements for single-use, gravity feed infusion sets for medical use in order
to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and
performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take
precedence over this part of ISO 8536.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given
in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet
devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated
in Figure 2 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used
for rigid containers.
ISO 8536-4:2004(E)
Key
1 protective cap of closure-piercing device 7 fluid filter
2 closure-piercing device 8 tubing
3 air inlet with air filter and closure 9 flow regulator
4 fluid channel 10 injection site
5 drip tube 11 male conical fitting
6 drip chamber 12 protective cap of male conical fitting

a
Closure of the air inlet is optional.

b
The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has
a nominal pore size of 15 µm.
c
The injection site is optional.
Figure 1 — Example of a vented infusion set
2 © ISO 2004 – All rights reserved

ISO 8536-4:2004(E)
Key
1 protective cap of the closure-piercing device 7 tubing
2 closure-piercing device 8 flow regulator
3 fluid channel 9 injection site
4 drip tube 10 male conical fitting
5 drip chamber 11 protective cap of the male conical fitting
6 fluid filter
a
The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has
a nominal pore size of 15 µm.
b
The injection site is optional.
Figure 2 — Example of a non-vented infusion set

ISO 8536-4:2004(E)
Key
1 protective cap 4 clamp
2 closure-piercing device or needle 5 air-inlet with air filter
3 tubing
a
Other designs are acceptable if the same safety aspects are ensured.
Figure 3 — Example of an air-inlet device
3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set
until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing
device or needle.
4 Designation
4.1 Infusion set
Infusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by the
descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the
letter G:
Infusion set ISO 8536-4 — IS — G
4.2 Air-inlet device
Air-inlet devices complying with the requirements specified in this part of ISO 8536 shall be designated by the
descriptor words, followed by a reference to this part of ISO 8536, followed by the letters AD:
Air-inlet device ISO 8536-4 — IS — AD
5 Materials
The materials from which the infusion set and its components as given in Clause 3 are manufactured shall
comply with the requirements as specified in Clause 6. Where components of the infusion set come into
contact with solutions, the materials additionally shall comply with the requirements as specified in Clauses 7
and 8.
4 © ISO 2004 – All rights reserved

ISO 8536-4:2004(E)
6 Physical requirements
6.1 Particulate contamination
The infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts
shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of
particles shall not exceed the contamination index.
6.2 Leakage
The infusion set, when tested in accordance with A.2, shall show no signs of air leakage.
6.3 Tensile strength
When tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile
force of not less than 15 N for 15 s.
6.4 Closure-piercing device
The dimensions of the closure-piercing device shall conform with the dimensions shown in Figure 4.
NOTE The dimension of 15 mm in Figure 4 is a reference measurement. The cross section of the piercing device at
this site is a circle.
The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container
without pre-piercing. No coring should occur during
...